More than 4.5 million Americans currently suffer from Alzheimer's Disease, a progressive neurodegenerative disease characterized by loss of memory, changes in personality, agitation, disorientation, loss of coordination, and finally, total loss of day-to-day functioning. Alzheimer's is a staggeringly expensive disease, costing the American economy more than $83.9 billion annually. The Alzheimer's Association estimates that by 2050 between 11.3 million and 16 million Americans will be Alzheimer's victims, and that the overall economic impact of the disease will increase four-fold. Much of the cost of Alzheimer's is born by Medicare and Medicaid. There is currently no treatment that halts the overall progression of the disease. As such, there is a great need for a significant breakthrough in Alzheimer's prevention and treatment. There is a growing consensus that Alzheimer's is a multifactorial disease and it is possible that a "cocktail" of medicines or ingredients may be needed to successfully delay its onset or progression. The Akeso Health Sciences (Akeso) medical food cocktail is composed of standardized herbal extracts, vitamins, and minerals that are demonstrated in the basic science and clinical medical literature to impact the biochemical and pathophysiological processes involved in Alzheimer's Disease. During Phase I of this SBIR project, the investigators formulated the cocktail and conducted initial feasibility tests on cognitive function in a transgenic mouse model of Alzheimer's Disease. The medical food cocktail was effective in preventing cognitive decline and reducing Alzheimer's-related neuropathology compared to transgenic mice on regular mouse chow only. Normal non-transgenic mice fed the cocktail exhibited improved cognitive function. For Phase II of this SBIR project, the investigators propose to test the efficacy of the cocktail in improving cognitive function in several animal models of Alzheimer's Disease that exhibit more advanced Alzheimer's-related neuropatholgies and severe neuronal loss. The cocktail will be tested in 2 additional transgenic mouse models and in a longitudinal study in an aged canine model. If such a medical food cocktail proves feasible and cost effective for use as a complementary or alternative therapy for Alzheimer's Disease, the devastating economical and societal costs of Alzheimer's may be drastically reduced. PUBLIC HEALTH RELEVANCE: Building on the results of a successful Phase I SBIR project, the investigators propose to test the efficacy of a medical food cocktail consisting of standardized herbal extracts, vitamins, and minerals in improving cognitive function in several animal models of Alzheimer's Disease. If effective for use as a complementary or alternative therapy, the medical food cocktail may drastically reduce the devastating economical and societal costs of Alzheimer's Disease.